A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy plus Trastuzumab plus Placebo versus Chemotherapy plus Trastuzumab plus Pertuzumab as adjuvant Therapy in Patients with Operable HER2-positive Primary Breast Cancer

Summary:
In this study, patients will be randomized and receive the study therapy of either trastuzumab plus pertuzumab or trastuzumab plus a placebo. Trastuzumab (Herceptin®) is a licensed treatment for patients with HER2 positive breast cancer. Pertuzumab is a research drug and is not yet licensed for HER2-positive breast cancer. Patients will undergo either trastuzumab plus pertuzumab or trastuzumab plus a placebo for a total of 6-8 cycles over the course of one year (52 weeks). All throughout the time of the study, patients will be carefully monitored by health professionals and patient progress will be assessed for safety and efficacy.

Eligibility:

Age 18 or older
Must have undergone either total masectomy or lumpectomy
Must agree to the use of a non-hormonal form of contraception
For patients who have undergone lumpectomy, the margins of the resected area must be free of invasive tumor and ductal carcinoma in situ (DCIS)

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